Setting standards in Clinical Outsourcing

This month’s blog is an account of the journey we took with one of the key membership organizations within the pharmaceutical industry. The organization in question was the Pharmaceutical Contract Management Group (PCMG). The goal was to help them establish a set of standards for R&D outsourcing and to develop a competence-based approach for their flagship training course, Outsourcing Essentials

Who or what is the PCMG?

The PCMG is the leading clinical outsourcing community and their aim is to foster a consistent, professional approach to managing R&D outsourcing. Their members are individuals, working in the pharmaceutical industry, who have significant roles in the selection and/or the management of outsourcing services related to drug development.

How did the relationship with PCMG come about?

A mutual contact put our two organizations in touch because of our common goal of improving standards in the clinical research sector. Our initial discussions with PCMG involved sharing ideas about how we could improve competence and best practice, specifically in the area of clinical research outsourcing. We then zeroed in on two specific projects.

Working with PCMG to create a Competency Framework for Clinical Outsourcing Managers

The first project involved supporting one of PCMG’s key objectives which is to establish standards and best practice for R & D outsourcing. We discussed with them the development of a competency framework for the job role of a Clinical Outsourcing Manager. The first step involved identifying all the tasks that need to be completed by a Clinical Outsourcing Manager during the outsourcing process. This enabled us, together with the PCMG, to identify the competencies that were necessary for the successful completion of each task and thereby use this as the basis for creating a competency framework for a Clinical Outsourcing Manager.

The second project was related to another of PCMG’s objectives which is to develop the skills of people working in clinical outsourcing. This involved accrediting PCMG’s flagship training course – Outsourcing Essentials.

What does PCMG want to achieve from the accreditation of their Outsourcing Essentials Training Course?

The purpose of the two day PCMG Outsourcing Essentials program is to enable participants to lead the outsourcing processes from vendor selection to contract close-out. The course includes overseeing the outsourcing process, financial and legal aspects, negotiations, relationship management, and performance management. By getting their course accredited, PCMG wanted to demonstrate their commitment to delivering a high-quality competence-based training program, which was aligned with the newly developed Clinical Outsourcing Manager competency framework.

What are the benefits of the Three Star Course Accreditation?

IAOCR Three Star Course Accreditation symbolizes that course materials are of high quality and that learners are given competence-based objectives in the relevant areas. The accreditation also ensures that the course provides an appropriate level of interaction rather than being merely a series of lectures, and that a variety of learning styles have been considered.

What happens next?

The course will be run for the first time under its accredited status in London on the 10th and 11th of April. To learn more about the course and register your interest CLICK HERE. Feedback from participants and trainers alike will be keenly sought so that we can demonstrate how the learnings from the course are being applied back on the job from both sides of the outsourcing coin – the pharma and CRO perspectives. Ultimately good outsourcing practice will lead to better outcomes for both the pharma and CRO sectors.

Watch this space to find out what happened when the course is run for the first time after its accreditation!